An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study)

Phase 4

Completed

• Conditions: inflammatory bowel disease; Ulcerative colitis; 10017969

• Registration Number: NL-OMON47577
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-06-20
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Age 18 to 80
2. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient.
3. Moderate to severe active UC (total Mayo score > 6) with objective evidence of inflammation that can be visualized on endoscopy. Patients must have an endoscopic Mayo score of 2 or 3.
4. Anti-TNF discontinued for at least 4 weeks before baseline;GROUP 1 (EARLY UC)
1. Diagnosis of UC < 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.
2. Demonstrated failure to respond to aminosalicylates or intolerance to aminoslicylates
and: failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
or: need for 1 course of steroids since diagnosis
and additionally, but not mandatory, lack of efficacy of thiopurines or intolerance to thiopurines (any duration). Patients who are using thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine) at screening must have used them for > 3 months (last 4 weeks at stable dose).;GROUP 2 (LATE UC);1. Diagnosis of UC > 4 years confirmed by clinical, endoscopic and histopathological evidence.
2. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates
and: failure to respond to at least 3 months of thiopurines or intolerance to TP
and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF. Loss of response to anti-TNF is defined as recurrence of symptoms during maintenance dosing following prior clinical benefit.

Exclusion Criteria

1. Prior treatment with vedolizumab; a4β7 anti-bodies ; β7 antibodies ; anti- MADCAM-1 .
2. History of colonic dysplasia or colonic cancer.
3. Extensive colonic resection, i.e. subtotal or total colectomy with <15 cm colon remaining
4. Received other biologics within the last 4 weeks of baseline
5. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
6. Chronic hepatitis B or C infection
7. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
8. Active or latent tuberculosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of patients with clinical and endoscopic<br /><br>remission at Week 26 and 52-54, defined as a Mayo Clinic score <=2 and no<br /><br>subscore >1 .</p><br>